CDSCO extends Covaxin’s shelf-life to 12 months from the date of manufacturing

The announcement comes just in time as the World Health Organisation has reportedly approved Bharat Biotech’s Covaxin for its Emergency Use Listing.

Advertisement

Vaccine maker Bharat Biotech on Wednesday, November 3 revealed that the shelf-life of its COVID-19 vaccine Covaxin has been extended to 12 months from the date of manufacture. Prior to this, the shelf-life of Covaxin had been set at 6 months from the date of manufacture, subject to its storage at two to eight degrees Celcius. 

In a statement, Bharat Biotech announced that the Central Drugs Standard Control Organisation (CDSCO) approved its request to extend the shelf-life of the vaccine based on additional stability data that the vaccine maker provided to the regulatory body. 

The announcement comes just in time as the World Health Organisation has reportedly approved Bharat Biotech’s Covaxin for its Emergency Use Listing after deliberating on the additional data provided to the Technical Advisory Group of the WHO by the Hyderabad-based company. 

Bharat Biotech had been looking to increase Covaxin’s shelf-life to 24 months from the date of manufacture and had sought permission for the same from the Drug Control General of India (DCGI) earlier this year in July. 

Covaxin has demonstrated 77.8 percent effectiveness against symptomatic COVID-19 and 65.2 per cent protection against the new Delta variant. Bharat Biotech had earlier stated that it has concluded the final analysis of Covaxin efficacy from Phase three trials.

Covaxin is currently one of two COVID-19 vaccines being widely administered in India and has been a crucial factor in the accelerated vaccination drive of India. Outside of India, the vaccine has received regulatory clearance in countries such as Iran, Mexico, Mauritius, Nepal, Oman and Greece. 

Australia became the latest country to join the list of nations to have recognised people administered with Covaxin as fully vaccinated on Monday, November 1. 

Subscribe to our newsletter
Subscribe to our newsletter
Sign up here to get the latest news delivered directly to your inbox.
You can unsubscribe at any time